Challenges in Bioanalytical Methods Validation A Critical Review of FDA Requirements
Aug 26 2008 - 5:30pm
Aug 26 2008 - 8:00pm
On Tuesday, August 26th, 2008 from approximately 5:30 to 8:00 in the evening, AAIPharma's VP of Bioanalytical Operation, Dr. Dari Dadgar, will be presenting and discussing the challenges of bioanalytical methods validation at The Angus Barn in Raleigh, NC.
Dari obtained his BS in chemistry and MS and Ph.D. in analytical chemistry from The Queen’s University in UK. He graduated in 1980. After a brief post-doctoral research he started his first job as a manager of bioanalytical laboratory in Dublin, Ireland and has ever since been involved in separation sciences in general and in chromatographic techniques as applied to bioanalytical in particular. His career spans working for 4 years in academia, Dublin City University, and in several CROs in Canada and United states. He has held managerial and research positions in Biovail Corp, Toronto, Canada, Bioresearch and Phoenix International, Montreal, Canada, Huntigdon Life Sciences and Biolytix in NJ where he established both laboratories from ground up and most recently as VP of Bioanalytical Operation for AAIPharma in Shawnee, Kansas.
Challenges in Bioanalytical Methods Validation – LC-MS/MS Based Methods A Critical Review of FDA Requirement Bioanalysis defined as the measurement of concentrations of drugs and metabolites in biological samples plays an important role in the evaluation and interpretation of bioequivalence, pharmacokinetic, and toxicokinetic studies. The quality of these studies is directly related to the reliability and the quality of bioanalytical data.
After several workshop deliberations organized by the FDA, the procedures for validation of bioanalytical methods to ensure their reliability are well established. These procedures involve establishment of parameters such as accuracy, precision, selectivity, sensitivity, reproducibility, recovery and different types of stability studies. However, in the view of author, some of these procedures although adequate, in particular stability studies which are the most time consuming and tedious, should be challenged to find the best scientific ways of conducting it.
Procedures to conduct a successful bioanalytical methods validation will be discussed and the wisdom of some procedures as written in the guidance is challenged and alternative, more scientific ways are presented.
